FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease
Stopped early
Conditions studied: Peripheral Vascular Disease
In brief
The specific aims of the project are as follows: To determine whether catheter-based revascularization procedures improve functional capacity and quality of life among patients with intermittent claudication. To investigate whether improvements in walking ability result in a less sedentary lifestyle and improvement of the cardiovascular risk profile.
Key facts
- Study ID
- NCT00274157
- Run by
- The Cleveland Clinic
- People needed
- 37
- Starts
- 2007-03-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2008-06-27
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies
- Critical limb ischemia (rest pain, non-healing ulcer, gangrene)
- Contraindication to contrast arteriography
- Vascular surgery or prior catheter-based vascular intervention within the preceding 6 months
- Patients with suspected or confirmed graft stenoses or occlusions
- Myocardial infarction or hospitalization for unstable angina, coronary artery bypass grafting or percutaneous coronary intervention, within the preceding one month
- Stroke or transient ischemic attack within the preceding one month
- Pregnancy or planned pregnancy during the one year of participation in the trial.
- Any active chronic inflammatory condition,including autoimmune disorder or active malignancy.Subjects unable to walk, amputees, and subjects with a contraindication to treadmill exercise.
- Patients with dementia or other significant cognitive impairment
- Patients who are non-English speaking, (due to the need for subjects to complete standardized questionnaires)
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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